Powder Inhaler Devices

ABSTRACT

An improved inhalation device is provided for facilitating inhalation by a patient of powder medicaments contained in a receptacle. The inhalation device includes a staple assembly comprising a plunger and staple that are securely and robustly coupled to one another. Embodiments of the inhalation device have a cap that prevents or reduces the amount of dust and grime entering into the device. The cap is additionally configured to prevent or reduce inadvertent and unintentional operation of the device. The body portion and first casing portion of certain embodiments of the inhalation device are sealably coupled, restricting or reducing undesirable flow pathways that have an adverse effect on the operation of the device.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/218,286, filed Jul. 25, 2016, which is a continuation of U.S.application Ser. No. 13/930,710, filed Jun. 28, 2013, now U.S. Pat. No.9,468,728, issued Oct. 18, 2016, which is a continuation of U.S.application Ser. No. 12/155,782, filed Jun. 10, 2008, now U.S. Pat. No.8,496,002, issued Jul. 30, 2013, which claims the benefit of U.S.Provisional Application No. 60/929,092, filed on Jun. 12, 2007. Theentire teachings of the above applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates generally to facilitating release ofpowder contained in a receptacle. More specifically, the presentinvention relates to the administration of medication by a method andapparatus for facilitating inhalation of powder medicaments.

Related Art

In the medical field, it is often desirable to administer various formsof medication to patients. Well known methods of introducing medicationinto the human body include the oral ingestion of capsules and tablets,intravenous injection through hypodermic needles, and numerous others.In one method, certain medications may be inhaled into a patient'srespiratory tract and lungs through the nose or mouth. Certain of thesemedications, such as bronchodilators, corticosteroids, etc., for thetreatment of asthma and other respiratory anomalies, may be aimed at therespiratory tract directly. Others are inhaled for purposes of systemictreatment, i.e. for treatment of any area of the body through absorptionfrom the respiratory tract through the lung tissue, into the deep lungs,and into the bloodstream. Each of these medications comes in a varietyof forms, including fluids, which are commonly administered as anaerosol vapor or mist, as well as solids. Inhalable solids typicallytake the form of fine, dry powders. Specialized devices, such asinhalers, are provided to assist the patient in directing these finepowder medications into the respiratory tract.

Various types of inhalers are known for the administration of dry powdermedicaments. However, each of these inhalers suffers certain drawbacks.For example, U.S. Pat. No. 5,787,881 discloses an inhaler that is usedwith encapsulated dry powder medicaments. However, use of this devicerequires numerous steps and imposes a number of inconveniences on auser. For example, the medication capsules used with the device have anaperture formed therein prior to insertion into an opening in theinhaler. Therefore, there exists a danger that an amount of medicationmay be lost prior to or during insertion into the device. Afterinsertion of the capsule, use of the device requires the additional stepthat a cover must be closed before the medication may be inhaled.

Inhalation devices configured for use with a capsule containing sometype of medicament are shown in U.S. Pat. No. 4,069,819 to Valentini etal. (“the '819 patent”) and U.S. Pat. No. 4,995,385 to Valentini et al.(“the '385 patent”). The inhalation device described in the '385 patentwas developed to overcome the drawbacks of the device described in the'819 patent. Particularly, in a large number of cases, the devicedescribed in the '819 patent experienced irregular and incompleteemptying of the capsule, thereby resulting in difficulties in properlyadministering the medicament in the capsule. The inhalation devicedescribed in the '385 patent attempts to overcome this deficiency bytapering the nebulization chamber toward the end surface that comprisesthe discharge holes. Thus, the nebulization chamber of the '385 patentis not cylindrical, but rather frusto-conical in form in an attempt toachieve regular complete emptying of the nebulization chamber.

However, further improvements in the design of inhalation devices areneeded to achieve high emitted doses and highly dispersed powders whilemaintaining low resistance, especially when the inhaler is used withhigh doses and is operated at low peak inspiratory flow rates (PIFR) andlow inhalation volumes. As used herein, “emitted dose” (ED) refers tothe percentage of the dose of powder medicament that is emitted from areceptacle in the inhalation device. The dispersal of the powder can bequantified by measuring the volume mean geometric diameter (VMGD) of theemitted powder. As used herein “volume mean geometric diameter” refersto the average geometric diameter of the powder. As used herein,“resistance” refers to the square root of the pressure gradient acrossthe inhaler divided by the peak inspiratory flow rate through theinhaler. As used herein “low peak inspiratory flow rate” refers to apeak inspiratory flow rate of approximately 25 L/min or less. Moreover,improvements are needed to achieve high emitted doses and highlydispersed powders that are consistently reproducible, i.e., that have alow standard deviation of emitted dose percentage and VMGD,respectively.

U.S. Pat. Nos. 6,766,799 and 6,732,732, which are assigned to the sameentity as the one to which the current application is under anobligation of assignment, disclose further improvements over previouslyknown devices. These patents disclose, among other things, a ring thatis circumferentially coupled to the inside of a chamber for receivingthe medicament capsule. Such a ring is intended to improve thereproducibility of the emitted dose during operation of the device. Thepatents also disclose staples of differing configurations for puncturingthe receptacle during operation of the device.

Another drawback of the inhalation devices described in the '819 and the'385 patents is the piercing device that is used to puncture thecapsule. Such conventional piercing devices are formed from circularstock, with the points created by pinching the stock at an angle,thereby creating a single sharp cutting edge. Drawbacks of such a designare that the point (which must puncture the capsule material) is oftenrounded, lessening its effectiveness as a piercing device. Moreover,burrs often form on the lower edge, which can stop the piercing devicefrom retracting from the capsule, thereby causing a device failure. Theholes formed by such a conventional piercing device are generally round,and do not have the appearance of being cut by a sharp edge. With such aconventional design, the capsule is often crushed, rather than puncturedor pierced. If such a conventional piercing device is used with brittlecapsule materials such as gelatin, pieces of capsule material of a sizethat can be inhaled are usually broken off from the capsule. Thus,conventional piercing devices are less than optimal, particularly forbrittle capsule material.

The co-owned '799 and '732 patents additionally disclose staples ofdiffering configurations and prongs for puncturing the receptacle duringoperation of the device. These configurations are intended to improvethe operation of the inhalation device. These patents also disclosemeans for indicating when the powder in the inhaler is ready forinhalation by the user, which is a useful improvement over devicespreviously known before the '799 and '732 patents. There is a need,however, for further improvements of such inhalation devices. Namely,there is a need for reliable attachment of the staple for puncturing thecapsule or receptacle to the rest of the device, considering therepetitive use and forceful impacts that the staple-device attachmentundergoes during operation. In addition, there is a need to reduce oreliminate the possibility of external dust and grime from entering andadversely affecting the operation of the device during periods ofnon-use, as well as periods of use. Additionally, there is a need toprevent inadvertent and unintentional operation of the device, whichmight occur when components of the device are subjected to random forcesthat trigger its operation without the volition of the user. Finally,there is a need for reducing undesired air flow into the inhaler deviceat its rest position, which has an adverse impact on the effectivenessof the device.

Thus, there is a need in the art for an improved method and apparatusfor facilitating inhalation of dry powder medicaments. What is needed isan inhaler that provides for reliable and robust attachment of thestaple, that prevents dust and grime from entering into the device andprevents unintentional operation of the device, and that reducesundesired air flow in to the inhaler device at its rest position.

SUMMARY OF THE INVENTION

In one embodiment of the invention, an inhalation device foradministering a dose of powder contained in a receptacle is provided.The inhalation device includes a first casing portion and a secondcasing portion movably coupled to the first casing portion. The secondcasing portion includes a mouthpiece portion and a chamber configured tohold the receptacle. A plunger is coupled to the first casing portion,movably coupled to the second casing portion, and additionally includesa notched end. The inhaler device includes a hook member that is coupledto the plunger in a manner that secures a substantially U-shaped stapleto the plunger.

In another embodiment of the invention, the plunger of the inhalationdevice has a substantially flat surface and includes at least oneprojecting portion that projects from the flat surface. The at least oneprojecting portion swagingly secures a U-shaped staple to the plunger.

In yet another embodiment of the invention, the base of the staple ofthe inhaler device has a thick cross section relative to the tines ofthe staple. One of the base and the plunger has at least one flange, andthe other has at least one corresponding projecting hook which isconfigured to receive the at least one flange.

In yet another embodiment of the invention, at least one tine is securedto the distal end of the plunger by injection molding the at least onetine in a volume of space within the distal end of the plunger.

Another embodiment of the invention provides for sealable coupling ofthe first casing portion and the body portion of an inhalation device ina rest position of the inhalation device. In this embodiment, an end ofone of the first casing portion and the body portion has a radiallyprojecting portion around its circumference, and an end of the other ofthe two has a concave cross section. Further, the radially projectingportion has a convex cross section. The coupling of the concave andconvex portions substantially provides a seal when the inhalation deviceis in its rest position.

Another embodiment of the invention also provides for sealable couplingof the first casing portion and the body portion of an inhalation devicein a rest position of the inhalation device. In this embodiment, aninsert element is receivably coupled to one of the first casing portionand the body portion. The insert element forms a closed curvesubstantially normal to an axis of substantial symmetry of at least oneof the first casing portion and the body portion. The insert element issealably coupled to both the first casing portion and the body portionin a rest position of the inhalation device.

Another embodiment of the invention provides a cap that encloses thesecond casing portion when the cap is engaged to the inhalation device,and additionally prevents the movement of the first casing portion ofthe inhalation device with respect to the second casing portion.

BRIEF DESCRIPTION OF THE FIGURES

The present invention is described with reference to the accompanyingdrawings. In the drawings, like reference numbers indicate identical orfunctionally similar elements.

FIG. 1 is a front view of one embodiment of an inhaler device that maybe used with embodiments of the present invention.

FIG. 2 is a cross-sectional view of the inhaler device of FIG. 1 takenalong a plane parallel to an axis of substantial symmetry of the device.

FIG. 3A is a side view of the distal end of a plunger in accordance withan embodiment of the invention.

FIG. 3B is a view in perspective of the distal end of the plunger ofFIG. 3A.

FIG. 3C is a top view of the distal end of the plunger of FIG. 3A.

FIG. 4A is a view in perspective of a plunger in accordance with anotherembodiment of the invention.

FIG. 4B is a view in perspective of the plunger in accordance with theembodiment of FIG. 4A in which a U-shaped staple is attached to an endof the plunger.

FIG. 5A is a view in perspective of a staple and plunger in accordancewith yet another embodiment of the invention.

FIG. 5B is a side view of the staple and plunger of FIG. 5A.

FIG. 5C is a cross-sectional view of the staple and plunger of FIG. 5A.

FIG. 5D is a view in perspective of an alternate embodiment of thestaple and plunger of FIG. 5A.

FIG. 5E is an enlarged view of the plunger of the embodiment of FIG. 5Dwithout the staple.

FIG. 5F is a cross-sectional view of an alternate embodiment of theplunger of FIG. 5D that has a staple assembly that includes a singletine.

FIG. 6A is a cross-sectional view of another embodiment of a staple andplunger in accordance with the invention.

FIG. 6B is a view in perspective of the staple and plunger of theembodiment of FIG. 6A.

FIG. 6C is a side view of the staple and plunger of the embodiment ofFIG. 6A.

FIG. 7A is a view of an inhaler without the mouthpiece portion attached.

FIG. 7B is two side views of the inhaler of FIG. 7A with the mouthpieceportion attached.

FIG. 7C is a view of a cap in accordance with an embodiment of theinvention.

FIG. 7D is two side views of the cap of FIG. 7C secured to an inhalerdevice.

FIG. 8A is two side views of an alternate embodiment of the cap of FIG.7C that is secured to an inhaler device.

FIG. 8B is two side views of yet another alternate embodiment of the capof FIG. 7C that is secured to an inhaler device.

FIG. 9A is a view of an inhaler device in accordance with an embodimentof the invention in which the body portion and the first casing portionof the inhaler device are sealably coupled at a rest position of thedevice.

FIG. 9B is an enlarged view of the sealable coupling of FIG. 9A.

FIG. 10A is a view of an alternate embodiment of the invention in whichthe body portion and the first casing portion of the inhaler device aresealably coupled at a rest position of the device through an insertelement.

FIG. 10B is an enlarged view of the insert element of FIG. 10A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Overview

The present invention provides an improved method and apparatus forfacilitating release of powder. In a preferred embodiment, the powder iscontained in a receptacle. As used herein, the term “receptacle”includes but is not limited to, for example, a capsule, blister, filmcovered container well, chamber, and other suitable means of storing apowder known to those skilled in the art. The present invention will bedescribed below in the context of a method and apparatus for dispensingdry powder medicaments for inhalation by a patient. However, it shouldbe apparent to one skilled in the art that the invention is not limitedto such an exemplary embodiment, and could be used for other purposes.

The methods of the present invention use an inhaler to dispense powderby inhalation. In embodiments of the invention, a user operates thedevice to puncture the receptacle to disperse powder in the chamber, andinhales the powder through the inhalation portion.

As used herein, “attachment” and “coupling” are intended to coverembodiments in which two pieces are removably or irremobably attached toone another, as well as embodiments in which the two pieces are fused orpermanently attached to one another.

Inhaler and Associated Method of the Present Invention

A front view of one embodiment of an inhalation device 100 is shown inFIG. 1. The rear view of device 100 is substantially identical to thefront view. Device 100 includes a first or lower casing portion 120 anda second or upper casing portion 130 removably coupled to first casingportion 120. Upper casing portion 130 and lower casing portion 120include a flattened region 132 and 122, respectively, for ease ofgripping the casing for use by a patient. Lower casing portion 120preferably includes an outer casing 126 and an inner casing 124 movablyreceived within outer casing 126. A removable cap 110 as shown in FIG. 1may be provided at the user or inhalation end of the device.

Preferred materials for device 100 include Food and Drug Administration(FDA) approved, USP tested plastics. Preferably, device 100 ismanufactured using an injection molding process, the details of whichwould be readily apparent to one skilled in the art.

FIG. 2 is a cross-section of device 100 taken along a plane that isparallel to the axis of substantial symmetry of device 100. As shown inFIG. 2, device 100 includes an inhalation or emitter portion 220.Inhalation portion 220 comprises a hemispheric region 222 that defines aplurality of apertures 224. It should be understood that the presentinvention is not limited to a particular number of apertures 224, andcan be configured such that at least one aperture 224 is provided. Aninhalation piece 226 is provided to allow for inhalation of themedicament by a user. Inhalation piece 226 can be configured as a mouthpiece for inhalation through a user's mouth. Alternatively, inhalationpiece 226 can be configured as a nose piece for inhalation through auser's nose. For purposes of this application, “mouthpiece” shall denotemouth pieces for inhalation through a user's mouth and nose pieces forinhalation through a user's nose, as well as other possibilities such asa piece for insertion in or on a tracheostomy tube in a patientundergoing, or who has had, a tracheotomy.

Device 100 includes a cylindrical chamber 210 that is defined by astraight wall 212 of circular cross-section. Chamber 210 has a proximalend 214 and a distal end 216. A plurality of vents 218 are defined bywall 212, and are configured for introducing air into chamber 210 todisperse powder released from a capsule 219. It should be understoodthat the present invention is not limited to a particular number ofvents 218, and can be configured such that at least one vent 218 isprovided. Powder released from capsule 219 is dispersed in chamber 210and inhaled through apertures 224 and inhalation piece 226 by the user.

In other embodiments of the invention, receptacles other than capsulesare used, such as blisters and film covered container wells as is knownin the art. In one embodiment, the volume of the receptacle is at leastabout 0.37 cm³. In another embodiment, the volume of the receptacle isat least about 0.48 cm³. In yet another embodiment, the receptacles havea volume of at least about 0.67 cm³ or 0.95 cm³. In one embodiment ofthe invention, the receptacle is a capsule designated with a capsulesize 2, 1, 0, 00, or 000. Suitable capsules can be obtained, forexample, from Shionogi (Rockville, Md.). Blisters can be obtained, forexample, from Hueck Foils, (Wall, N.J.).

The receptacle encloses or stores particles, also referred to herein aspowders. The receptacle is filled with particles in a manner known toone skilled in the art. For example, vacuum filling or tampingtechnologies may be used. Generally, filling the receptacle with powdercan be carried out by methods known in the art. In one embodiment of theinvention, the particle or powder enclosed or stored in the receptaclehave a mass of at least about 5 milligrams (mg). In another embodiment,the mass of the particles stored or enclosed in the receptacle is atleast about 10 mg, and up to approximately 50 mg. In a preferredembodiment, the mass of the particles is approximately 20 mg.

In one embodiment of the present invention, particles used with thedevice have a tap density of less than about 0.4 g/cm³. Particles havinga tap density of less than about 0.4 g/cm³ are referred to herein as“aerodynamically light”. In a preferred embodiment, the particles have atap density of near to or less than about 0.1 g/cm³. Tap density is ameasure of the envelope mass density characterizing a particle. Theenvelope mass density of particles of a statistically isotropic shape isdefined as the mass of the particle divided by the minimum sphereenvelope volume within which it can be enclosed. Features that cancontribute to low tap density include irregular surface texture andhollow or porous structure. Particularly preferred particles and powdersare described in U.S. Pat. Nos. 6,136,295, 5,985,309, 5,874,064,5,855,913 and 6,858,199, filed Jun. 9, 2000 entitled “High EfficientDelivery of a Large Therapeutic Mass Aerosol”, the entirety of each ofthe foregoing patents and patent applications is hereby incorporatedherein by reference.

Device 100 includes a staple assembly 230 that is used to puncturecapsule 219 to release powder contained therein into chamber 210. In theembodiment shown in FIG. 2, staple assembly 230 includes at one end asubstantially U-shaped staple 232 that has two prongs. In thisembodiment, each of the prongs of U-shaped staple 232 is configured witha square cross-section 234, thereby providing a sharp point and twocutting edges.

Previously known staple assemblies for puncturing a receptacle orcapsule in inhaler devices include prongs (or tines) that have wide,broad surfaces that are intended as puncturing edges. Although suchstaple assemblies may be used with embodiments of the invention, moreeffective puncturing of the receptacle may be achieved using stapleassemblies with prongs that have sharp points. Wide broad surfacesrequire greater force to puncture a rounded surface such as a capsule,causing the capsule to buckle in an undesirable way. Staple assembliesthat have prongs with sharp points for puncturing, as disclosed, forexample, in U.S. patent application Ser. No. 10/771,551, which isassigned to the same entity to which the present application is under anobligation of assignment, do not present such problems. For that reason,preferred embodiments of the invention, as disclosed below, utilizestaple assemblies that have prongs with sharp puncturing points.

The inhaler of the present invention is preferably configured with astaple assembly for puncturing the receptacle that improves puncturingperformance, particularly with brittle receptacle material. In onepreferred embodiment, the staple assembly for puncturing the receptacleof the present invention includes as a substantially U-shaped staplethat is attached to a plunger, with each of the two prongs of theU-shaped staple having a sharp point and two cutting edges. In one suchembodiment, each prong has a square cross-section, with the staplematerial being bent around a face so that the innermost part of theU-shaped staple is flat. In another such embodiment, the staple materialis rotated 45 degrees so that it is bent around an edge so that theinnermost part of the U-shaped staple is an edge. In such an embodiment,the end surface of each prong is an angled diamond-shaped surface.

In another preferred embodiment, the staple assembly for puncturing thereceptacle is configured as a substantially longitudinal prong that isattached to a plunger, with the prong comprising a puncturing surface onthe distal end, a primary cutting surface running from the proximal endto the distal end of the prong and terminating at the puncturingsurface, and a substantially planar face opposite to the primary cuttingedge and running from the proximal end to the distal end of the prong.The prong preferably has an angled surface at the distal end, the angledsurface having a distal end terminating at the puncturing surface and aproximal end terminating at the substantially planar face. In addition,the prong is preferably tapered so that the distal end is smaller thanthe proximal end, to facilitate removing the prong from a receptacle.The prong also preferably has a plurality of longitudinal faces and aplurality of longitudinal edges running from the proximal end to thedistal end of the prong.

The prong is configured to create an opening in a wall by forming ahanging chad in the wall, the hanging chad having a free end formed bythe puncturing surface and the primary cutting edge and a hinge coupledto the wall formed by the face. In a preferred embodiment, the prong isconfigured to open the hanging chad to an angle of at least 30 to 45degrees between the minor axis of the receptacle and the hanging chad,wherein the minor axis is substantially perpendicular to a longitudinalaxis of the receptacle, which is substantially parallel to thelongitudinal prong.

Other embodiments of staple assemblies for puncturing a capsule aredisclosed and discussed in U.S. Pat. Nos. 6,766,799 and 6,732,732, whichare herein incorporated by reference in their entirety.

Staple assembly 230 is preferably configured to be movable between anon-puncturing position (as depicted in FIG. 1) and a puncturingposition. In the puncturing position, prongs 232 pierce or puncturecapsule 219 to make holes therein. In a preferred embodiment, a meansfor biasing is provided that biases staple assembly 230 in thenon-puncturing position. In the embodiment shown in FIG. 2, the meansfor biasing is configured as a spring 242 that biases the substantiallyU-shaped staple (and staple assembly 230 to which it is attached) in thenon-puncturing position.

As noted with respect to FIG. 1, device 100 includes inner casing 124and outer casing 126. As shown in FIG. 2, a spring 244 is disposed inlower casing portion 120 that biases inner casing 124 in an outwardposition. Upon compression of spring 244, inner casing 124 moves fromthe outward position to an inward position, thereby drawing lower casingportion 120 toward upper casing portion 130. Compression of spring 244also causes compression of spring 242, thereby causing staple assembly230 to move to the puncturing position. Upon release of compression,springs 242 and 244 return to their biased state, thereby returningstaple assembly 230 to its non-puncturing position, and inner casing 124to its outward position.

A pair of flanges 252 is disposed on first casing portion 120. A pair ofgrooves 254 is disposed on second casing portion 130 so that flanges 252can be received within grooves 254 to thereby couple the first andsecond casing portions. Preferably, the first and second casing portionsare coupled with a friction-fit engagement. A friction-fit engagementcan be achieved using the groove and flange arrangement depicted in FIG.2. Other alternative configurations for a friction-fit engagement wouldbe readily apparent to one skilled in the art.

In the inhaler of FIG. 2, staple 232 is one part of the single piecethat is the staple assembly 230. In certain embodiments of the currentinvention, the staple assembly comprises at least two parts, a stapleand a plunger, with the staple attached at the distal end of theplunger. FIGS. 3A, 3B and 3C show the distal end 310 of plunger 395 ofstaple assembly 230, in a first such embodiment of the presentinvention. The term “distal end”, when used in reference to the plunger,denotes the end of the plunger that is furthest from the first casingportion (i.e., the end that is nearest the mouth or nose of the userwhen the device is in operation.) FIG. 3A illustrates distal end 310 ofthis embodiment in profile, with the line of sight substantiallyperpendicular to each of the axes of substantial symmetry of plunger 395and distal end 310. FIG. 3B illustrates distal end 310 in perspective,from a line of sight forming an obtuse angle with these axes. FIG. 3Cshows a view of distal end 310 looking down along the axes of plunger395 and distal end 310. In this embodiment, distal end 310 is formed tocontain notch 330, which provides the space in which the means for thestaple attachment and the staple are situated. In this embodiment, hook320, which is attached to distal end 310 and functions as the means forattaching a staple to distal end 310, is configured to fix a staple (notshown in FIG. 3 but similar, for example, to U-shaped staple 490 of FIG.4B) to distal end 310 by compression of the staple between hook 320 anddistal end 310. In the configuration in which the staple is attached tothe distal end 310, the bottom of the U-part of the staple threadsthrough slot 350, which is formed from a gap between hook 320 and distalend 310. In an aspect of this embodiment (shown in FIG. 3A), grooves340, located substantially diametrically opposed from one another alonga cross section of distal end 310, provide support for the sides of theU-shaped staple, which provides further compressive support in fixingthe U-shaped staple to distal end 310. The staple and hook 320 may befixed onto distal end 310 during manufacture of plunger 232 through, forexample, injection molding, in a manner that will be apparent to thoseof skill in the art. In preferred embodiment, hook 320 is made from thesame material as distal end 310, and is fused by injection molding ontoit.

FIGS. 4A and 4B show another embodiment of staple assemblies inaccordance with the invention, in which a staple, for example, theU-shaped staple 490 of FIG. 4B, is swagingly secured to distal end 410of plunger 495. FIG. 4A illustrates plunger 495 in the configurationbefore attachment of U-shaped staple 490. Here, plunger 495 contains oneor more projecting portions 420 that project substantiallyperpendicularly from a surface of distal end 410, which in theembodiment illustrated in FIG. 4A is substantially flat. Projectingportions 420 in FIG. 4A are arranged circumferentially around portion430 of distal end 410, which is configured to receive the staple. Inother aspects of this embodiment, any number of similar projectingportions may be present, each located either circumferentially within oraround portion 430. Portion 430 may contain one or more grooves 435 asshown in FIG. 4A that are shaped to receive the staple; such aconfiguration may provide better slippage-free attachment of the stapleto distal end 410. Further, as shown in the embodiment of FIG. 4A,distal end 410 may additionally include a retaining projecting portion445 that is used for vertical retention of plunger 495.

FIG. 4B illustrates plunger 495 in a configuration in which U-shapedstaple 490 has been swagingly secured to distal end 410. During theswaging process, projecting portions 420, which in this embodiment aremade from plastic, are heated and swaged down to compress U-shapedstaple 490 against the substantially flat surface of distal end 410 intoa fixed configuration. Upon cooling of the swaged projecting portions420, U-shaped staple 490 is fixed to distal end 410 as shown in FIG. 4B.Retaining projecting portion 445 of this embodiment is not swaged andremains in a projecting configuration, as depicted in FIG. 4B.

FIGS. 5A through 5F show another embodiment of a staple assembly inaccordance with the invention in which the staple includes a thick basethat is movably received within hooks projecting from the sides of thedistal end of the plunger. FIG. 5A illustrates distal end 510, withstaple 530 mounted thereon, in perspective, from a line of sight formingan obtuse angle with the axis of substantial symmetry of distal end 510.FIG. 5B shows the same configuration in profile, with the line of sightsubstantially perpendicular to that axis. FIG. 5C shows a cross sectionof the same configuration taken along a plane that is parallel to theaxis of distal end 510. In this embodiment staple 530 comprises a thickbase 540 and one or more tines 550 that provide the puncturingfunctionality. Distal end 510 includes projecting hooks 520 that projectfrom distal end 510. In the embodiment shown in FIG. 5A, two suchprojecting hooks are present, each diametrically opposed to the other.These hooks provide rails through which corresponding flanges at thebase of thick base 540 (not shown) are movably received; preferably, thecombination is configured to provide friction-fitted engagement.Attachment of staple 530 to distal end 510 is provided in this way inthe embodiment shown in FIGS. 5A-5C. Alternatively, securable attachmentof staple 530 to distal end 510 may be provided by, for example,including a groove (or rib) at a predetermined location along the innersurface of projecting hook(s) 520, and a corresponding rib (or groove)on the surface of the flange(s) at the base of thick base 540 (notshown). Such a groove (or rib) on the inner surface of projectinghook(s) 520 corresponds to the rib (or groove) on the surface(s) of theflange at the base of thick base 540, allowing staple 530 to snap into asecurably attached configuration within projecting hooks 520 of distalend 510. Other means for securably attaching staple 530 to distal end510 will be apparent to those of skill in the art based on the presentdisclosure.

FIG. 5D shows another version of the thick-based staple embodiment ofFIGS. 5A-5C. In this embodiment, projecting hooks 520 of distal end 510include a perpendicular member 525 that provides support and a greatercompressive force for increasing the effectiveness of thefriction-fitting engagement of projecting hooks 520 with thecorresponding flanges at the base of thick base 540. Perpendicularmember 525 also increases the strength and durability of projectinghooks 520. In this embodiment, the extension of the perpendicular member525 beyond the upper surface of projecting hooks 520 is for the purposeof interacting with an adjacent part (not shown) to limit the loadand/or impulse applied directly to staple 530; any such load or impulseis transferred to perpendicular member 525, thereby limiting thestresses applied to projecting hooks 520 by staple 530. This increasesthe durability of the design of this embodiment.

FIG. 5E shows only distal end 510 (including projecting hooks 520 andperpendicular member 525) of the embodiment of FIG. 5D without staple530 attached thereon. FIG. 5F shows an embodiment that is similar to theembodiment of FIGS. 5D and 5E in which only a single tine (tine 550) ispresent on staple 530.

FIGS. 6A-6C illustrate yet another embodiment of a staple assembly inaccordance with the present invention in which one or more tines areinsert molded onto the distal end of the plunger. FIG. 6A shows a crosssection of plunger 695 of this embodiment, including distal end 610 andtines 650, taken along a plane that is parallel to the axis ofsubstantial symmetry of plunger 695. In this embodiment, distal end 610of plunger 695 has a cylindrical shape that provides a cylindricalvolume 630 in which the bases of one or more tines 650 (i.e., prongs)are secured by injection molding of plastic within the cylindricalvolume.

In this embodiment, the base of cylindrical volume 630 is bounded by acylindrical plate 615, which provides separation of the injected-moldedplastic within cylindrical volume 630 from the rest of the interior ofdistal end 610.

FIG. 6B illustrates the embodiment of FIG. 6A in perspective, from aline of sight that forms an obtuse angle with the axis of substantialsymmetry of distal end 610. Similarly, FIG. 6C illustrates the sameembodiment in profile, with the line of sight substantiallyperpendicular to the axis of distal end 510.

FIGS. 7C and 7D illustrate another embodiment of the present inventionin which a cap is provided over the inhaler device of FIGS. 7A and 7B ina manner that prevents dust and grime from entering into the device. Thecap additionally prevents inadvertent and unintentional operation of thedevice, which might occur when components of the device are subjected torandom forces that trigger its operation without the volition of theuser.

FIGS. 7A and 7B illustrate an inhaler device, for example, similar tothe inhaler devices disclosed in U.S. Pat. Nos. 6,766,799 and 6,732,732.The inhaler device of FIGS. 7A and 7B comprises first casing portion 710that is movably coupled to second casing portion 720. Second casingportion 720 comprises mouthpiece portion 725 and body portion 730. Bodyportion 730 includes vents 740 on its distal end, similar to and havingthe same functionality of vents 218 of FIG. 2. The inhalation device ofFIGS. 7A and 7B may contain additional components, such as a stapleassembly for puncturing and a capsule containing a dry-powdermedicament, for example, as illustrated in FIG. 2, or in accordance withany other embodiment of staple assemblies of the invention. The inhalerdevice of FIGS. 7A and 7B is operated by compressing first casingportion 710 against second casing portion 720, which causes a stapleattached to the spring-loaded plunger to pierce the capsule. The usermay simultaneously or shortly thereafter inhale the dry-powdermedicament through mouthpiece portion 725, which provides a path forflow for the medicament from the pierced capsule through vents 740 tothe user's mouth.

FIGS. 7C and 7D illustrate a cap in accordance with one embodiment ofthe current invention for use with inhalers similar to the inhalerdevice of FIGS. 7A and 7B. Cap 750, as illustrated in FIG. 7D, may beplaced on the inhaler device in a configuration in which it enclosessecond casing portion 720 and is securably attached to first casingportion 710. Cap 750 may be securably attached to first casing portion710 in any way that will be apparent to one of ordinary skill in the artbased on the present disclosure; for example, an approximately circularrib 755 (or groove) (see FIG. 7C) may be formed within the internalsurface of cap 750 along the circumference of the intersection of aplane substantially perpendicular to the axis of substantial symmetry ofcap 750 with cap 750. Similarly, a corresponding approximately circulargroove (or rib) may be formed on the outer surface of first casingportion 710. Thus, cap 750 may be securably attached to first casingportion 710 by a snapping action, which causes the approximatelycircular rib 755 to move into place within the correspondingapproximately circular groove.

When cap 750 is securably attached to first casing portion 710 as shownin FIG. 7D, the probability of dust and grime entering into the inhaleris reduced, because in this configuration cap 750 encloses mouthpieceportion 725 as well as body portion 730 of second casing portion 720.Further, because operation of the inhaler device is caused by pushingfirst casing portion 710 against second casing portion 720, and becausethe presence of cap 750 on the inhaler device in a securably attachedconfiguration prevents or reduces relative motion of first casingportion 710 with respect to second casing portion 720, cap 750 in thesecurably attached configuration also prevents inadvertent operation ofthe inhaler device by the application of random forces to the deviceduring periods when it is not in use.

FIGS. 8A and 8B depict other example embodiments of the cap of thepresent invention. The inhaler of FIG. 8A has a cap 850 that enclosesall of the second casing portion (not shown) and that is coupled tofirst casing portion 810 in the inhaler device's closed position in amanner so that cap 850 only encloses a substantially small amount of thesurface area of first casing portion 810. The inhaler of FIG. 8B has acap 890 that encloses all of the second casing portion (not shown), andis coupled to first casing portion 860 in the inhaler device's closedposition in a manner so that cap 890 substantially does not enclose anyof the surface area of first casing portion 860. In this embodiment,when the inhaler device is in its closed position with cap 890 secured,the edges of the open end of cap 890 sit flush against the edges of theopen end of first casing portion 860. Securable attachment of cap 890 tofirst casing portion 860 may be achieved through a snapping mechanism inthis embodiment, for example, by placing a corresponding rib-groove pairalong these edges of cap 890 and first casing portion 860.

FIGS. 9A and 9B show another embodiment of the present invention thatreduces undesired air flow into the inhaler device at its rest positionby providing a substantially air-tight seal between the first casingportion and the body portion at that position. FIG. 9A illustrates, incross-sectional profile, an inhaler device in accordance with thisembodiment that is in its rest position. The inhaler device of FIG. 9Amay, for example, have substantially similar components to the inhalerdevice of FIG. 2 (or an inhaler device in accordance with any otherembodiment of the invention), such as first casing portion 910, secondcasing portion 920 (including mouthpiece portion 925 and body portion930), plunger 995 and chamber 945. In this embodiment, correspondingstructures at each of the distal ends of first casing portion 910 andbody portion 930 are sealably coupled at the rest position of theinhaler device. Portion 990 of the inhaler device of FIG. 9A is shown inexploded view and greater detail in FIG. 9B. In this embodiment, bodyportion 930 at its distal end and outer surface has a radiallyprojecting portion 970. The cross-section of the tip of radiallyprojecting portion 970 forms a convex curve, as shown in FIG. 9B. Thecorresponding portion 960 of first casing portion 910 that is coupled tothe tip of radially projecting portion 970 at the rest position of theinhaler device forms a concave curve, as shown in FIG. 9B. The convextip of projecting portion 970 and the corresponding portion 960 areshaped correspondingly so that they contact one another along a finitesurface area of each. A substantially air-tight seal may result from thecontact of such corresponding portions in such a manner; in particular,the biasing force of the springs in plunger 995 in the embodiment ofFIGS. 9A and 9B causes these corresponding portions to push against oneanother, which results in a frictional seal.

Other embodiments for achieving such a substantially air-tight seal willbe apparent to those with ordinary skill in the art based on the presentdisclosure. For example, in an embodiment that is the converse of theembodiment of FIGS. 9A and 9B, first casing portion 910 may have aprojecting portion that forms, in cross section, a convex curve on atits distal end and on its inner surface, whereas body portion 930 at thecorresponding position at its distal end and outer surface may form, incross section, a corresponding concave curve. These components, whichwill be in contact at the rest position of the inhaler device of thisembodiment, may once again form a substantially air-tight seal. In theembodiments of FIGS. 9A and 9B and its variations, the curves arepreferably smooth curves, in that tangents to each curve arewell-defined at all points along the curve. In other embodiments, thecurves are smooth only along sections of contact of body portion 930 andfirst casing portion 910.

FIGS. 10A and 10B illustrate another embodiment of the present inventionfor reducing undesired air flow into the inhaler device at its restposition by providing a substantially air-tight seal between the firstcasing portion and the body portion at the rest position. FIG. 10A showsan embodiment of the inhaler device of this embodiment at its restposition that has components substantially similar to those of theinhaler device of FIG. 2, such as first casing portion 1010, secondcasing portion 1020 (including mouthpiece portion 1025 and body portion1030) and plunger 1095. The inhaler device of the embodiment of FIG. 10Aadditionally contains insert element 1050.

Portion 1090 of the inhaler device of FIG. 10A, including insert element1050, is shown in exploded view and greater detail in FIG. 10B. Insertelement 1050 is receivably and sealably coupled to the distal end offirst casing portion 1010. For example, in a preferred embodiment,insert element 1050 is ultrasonically welded to the distal end of firstcasing portion 1010. Additionally, as shown in FIGS. 10A and 10B, insertelement 1050 is sealably coupled to body portion 1030 at the restposition of the inhaler device. For example, the biasing force of thesprings in plunger 1095 may cause a surface of insert element 1050 topush against a corresponding surface at the distal end of body portion1030 at the rest position of the inhaler device, which results in africtional seal. Such corresponding surfaces on insert element 1050 andthe distal end of body portion 1030 are normal to the axis of theinhaler device in the embodiment illustrated in FIGS. 10A and 10B. Otherembodiments will be apparent to those of skill in the art based on thepresent disclosure; for example, in an embodiment that is converse tothe embodiment of FIGS. 10A and 10B, insert element 1050 may bereceivably and sealably coupled to the distal end of the body portion.In this embodiment, insert element 1050 is also sealably coupled to thefirst casing portion at the rest position of the inhaler device.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. For example, the present invention isnot limited to the physical arrangements or dimensions illustrated ordescribed. Nor is the present invention limited to any particular designor materials of construction. As such, the breadth and scope of thepresent invention should not be limited to any of the above-describedexemplary embodiments, but should be defined only in accordance with thefollowing claims and their equivalents.

What is claimed is:
 1. An inhalation device for administering a dose ofpowder contained in a receptacle, said device comprising: a first casingportion; a second casing portion movably coupled to said first casingportion, said second casing portion including a mouthpiece portion and achamber configured to hold the receptacle; a plunger coupled to saidfirst casing portion and movably coupled to said second casing portion,said plunger including a notched end; a hook member coupled to saidplunger, and a substantially U-shaped staple coupled to said plunger,wherein the notched end and said hook member cooperatively secure thesubstantially U-shaped staple.
 2. The inhalation device of claim 1,wherein said substantially U-shaped staple is secured substantiallyparallel to an axis of said plunger.
 3. The inhalation device of claim1, wherein said hook member is fused to said plunger.
 4. The inhalationdevice of claim 1, wherein said plunger further comprises at least onebiasing spring, and wherein movement of said plunger with respect tosaid second casing portion is based on said at least one biasing spring.5. An inhalation device for administering a dose of powder contained ina receptacle, said device comprising: a first casing portion; a secondcasing portion movably coupled to said first casing portion, said secondcasing portion including a mouthpiece portion and a chamber configuredto hold the receptacle; a plunger movably coupled to said first casingportion and said second casing portion, said plunger including a distalend; and at least one staple tine molded to the distal end.
 6. Theinhalation device of claim 5, wherein said at least one staple tine issubstantially parallel to an axis of said plunger.
 7. The inhalationdevice of claim 6, wherein the distal end has a cylindrical shape thatprovides a cylindrical volume in which bases of one or more tines aresecured by injection molding.
 8. The inhalation device of claim 7,wherein a base of the cylindrical volume is bounded by a cylindricalplate which provides separation of injected-molded plastic within thecylindrical volume and an interior of the distal end.
 9. The inhalationdevice of claim 6, wherein two tines are injection molded in the distalend.
 10. The inhalation device of claim 9 wherein each tine ischaracterized by a groove at its base within the distal end.
 11. Thedevice of claim 9, wherein each tine is characterized by a sharppuncturing point.
 12. The device of claim 11, wherein each tine ischaracterized by a substantially planar face opposite to a primarycutting edge and running along the length of the tine.
 13. The device ofclaim 12, where each tine is characterized by an angled surface at thedistal end terminating at the sharp puncturing point and at thesubstantially planar face.
 14. The device of claim 13, wherein each tineis characterized by a plurality of longitudinal faces and edges runningfrom the proximal end to the distal end of the tine.
 15. The device ofclaim 1, further comprising a pharmaceutical formulation comprising atherapeutic agent.
 16. The device of claim 5, further comprising apharmaceutical formulation comprising a therapeutic agent.
 17. A kitcomprising a device of claim 1 and at least one capsule comprising apharmaceutical formulation comprising a therapeutic agent.
 18. A kitcomprising a device of claim 5 and at least one capsule comprising apharmaceutical formulation comprising a therapeutic agent.